Solution Protocols

Blockchain-based Solutions for the Modern Pharmaceutical Supply Chain

The MediLedger Project was started in 2017 to explore if blockchain could provide advantageous solutions as the DSCSA regulation required increasing interoperability in industry. From that work, we are testing and developing a variety of solutions to run on the network that can help companies comply with the regulations in place, and more:

solution protocol

Saleable Returns / Verification

The MediLedger Project was born to meet the demands of the Drug Supply Chain Security Act (DSCSA). ‍Beginning November 27th, 2019, the US pharmaceutical industry will be bound by new regulations set out by the Drug Supply Chain Security Act. One important component of these regulations is a provision that states that all prescription medicine returned to distributors must have their unique product identifiers verified with the manufacturer before being resold.

The MediLedger Project has developed a network to meet the demands of this new set of regulations. This network combines a Look-Up Directory accessed through a blockchain with a permissioned messaging network that allows companies to securely request and respond to product identifier verification requests.

Only authorized companies can put their products in the Lookup Directory. We have also created the functionality that allows products that have been sold to other companies to transfer that accountability, even before the NDC changes.

MediLedger Saleable Returns

The customer is in control. By leveraging Smart Contracts, you are the only one that can transfer ownership of a GTIN or Company Prefix.

IT Choices

On-PremHostedUse Preferred Service Provider

Performance

The industry tests executed in June show a response time of 100ms or less within the same region and 400ms for Coast-to-Coast verifications.

Industry First, Open to all

Designed with openness in mind. It is a great fit for Solution Providers and also self-service distributors and manufacturers. Any of them can join, build their solution and deliver their services for their customers or themselves.

Resilience and Security

No central system that can be compromised. A compromised Private Node does not impact the rest of the network.

Interoperable

Via Gateways, the MediLedger Network synchronizes with other VRS solutions using the HDA specification, and translate verification requests as needed.

Our tests to date show the ability to respond sub-second - meeting the industry requirements and keeping the supply chain moving.‍This solution will continue testing with our working group Pharma Trading Partners and Solution Providers, with commercial launch targeted for October, 2018.‍To learn more, please reach out to Chronicled or one of the solutions providers.

Enhanced Drug Verification

With the implementation of drug verification for Saleable Returns, the functionality can be enhanced to improve the verification requirements manufacturers already have today. Instead of manual processes involving phone calls and emails, pharmacies and hospitals can benefit from automated authenticity responses in sub second fashion. ‍Our working group is establishing requirements with an aim to conduct testing in Q4 2018.

solution protocol

Confidential Change of Ownership

The DSCSA requires an electronic interoperable system by 2023, replacing the manual transfers being put in place today. A decentralized and secure blockchain offers an ideal solution to record changes in ownership or prescription medicine and provide evidence of its Transaction History.‍The MediLedger Network CCO protocol enforces business rules to meet the industry’s needs:

It ensures only the rightful manufacturer can commission serial numbers on the blockchain and reduces the ability for counterfeiters to enter the supply chain.

It verifies that transactions are legitimate between trading partners by allowing unique identifiers to exist only in one place in the system at any given time, and only with the permission of the “rightful custodian”. This assists in rapid detection of diversion and illicit behavior.

It accelerates investigations into suspect products and enables rapid recalls because all network participants are able to respond in parallel.

It allows for all business rule enforcement without sharing data using the power of zero- knowledge proofs. This privacy feature allows the drugs to pass through many owners and allow verification at each step without needing to reveal the overall provenance of the drug to each player.

The MediLedger Project working group has defined these priorities for a blockchain network specifically for the needs of the pharmaceutical sector. We will begin testing these solutions in the first half 2019 and deploy the ledger commercially later in 2019.

solution protocol

Contracting and Chargebacks

Pharma industry payments involve multiple parties and complicated contract terms that can frequently require manual dispute resolution. Blockchain is an ideal solution to provide long term relief of this problem. ‍We have started a working group with major manufacturers, wholesalers, and GPOs to explore if blockchain can solve the complexities around contracting and chargebacks workflows. If you are interested in joining, please contact us.

Future Use Cases

As the network grows we intend to make specifications available for third party developers to create a marketplace of functionality to serve the pharmaceutical industry.

If you are interested in developing future applications, please contact us to get on our mailing list so we can keep you informed as our platform is established and specifications become available.